Multidomain Intervention to Prevent Disability in Elders (MINDED)

August 27, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montfaucon, France, 46240
        • Centre de Rééducation Fonctionnelle "La Roseraie"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of 60 years and older;
  • Willingness to be randomized to either treatment group;
  • Pre-frailty or frailty status according to the phenotype described by Fried and colleagues

Exclusion Criteria:

  • Failure to provide informed consent;
  • Inability to complete a 400-meter walk test (primary outcome of the study);
  • Living in nursing home;
  • Living outside of the area of interest, or planning to move out of the area in next 3 years, or planning to leave the area for more than 3 months during the next year;
  • Relevant cognitive impairment (defined as a known diagnosis of dementia);
  • Severe progressive, degenerative neurologic disease (e.g., multiple sclerosis);
  • Severe rheumatologic or orthopaedic diseases (e.g., awaiting joint replacement);
  • Terminal illness with life expectancy less than 12 months;
  • Severe pulmonary disease (e.g., oxygen therapy or chronic use of steroids);
  • Severe cardiac disease (e.g., New York Heart Association Class III or IV heart failure, clinically significant aortic stenosis, history of cardiac arrest, uncontrolled angina);
  • Other significant comorbid conditions that would impair the ability to participate in the multidomain intervention (e.g., renal failure on hemodialysis, severe psychiatric disorder, excessive alcohol use). To be noted: persons with depression will not be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Intervention group
Comprehensive geriatric assessment followed by multi-domain preventive intervention
Other: Multidomain intervention
Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
400-meter walk test
Time Frame: 12 months
Incident inability to complete the 400-meter walk test in the two randomization groups
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants' adherence/retention to the intervention protocol and control groups
Time Frame: 12 months
Participants' adherence/retention to the intervention protocol
12 months
Intercurrent illnesses rates
Time Frame: 12 months
Intercurrent illnesses rates in the two randomization groups
12 months
Serious fall injuries
Time Frame: 12 months
Incident fall injuries occurred in the two randomization groups
12 months
Hospitalizations and institutionalization rates
Time Frame: 12 months
Incidence of acute care hospitalizations and nursing home admissions in the two randomization groups
12 months
Mortality
Time Frame: 12 months
Overall mortality rate in the two randomization groups
12 months
Health-related quality of life
Time Frame: 12 months
Modifications of health-related quality of life in the two randomization groups
12 months
Body composition modifications
Time Frame: 12 months
Body composition modifications (assessed using bioimpedance analysis) in the two randomization groups
12 months
Modification of Pain
Time Frame: 12 months
Modification of pain symptoms in the two randomization groups
12 months
Fatigue
Time Frame: 12 months
Modification of the fatigue symptom in the two randomization groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Agency, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matteo Cesari, MD, PhD, Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C12-55
  • 2013-A00380-45 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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